CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE; CELECOXIB

All Clinical Trials for AMLODIPINE BESYLATE; CELECOXIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02172040 ↗	Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy	Completed	Kitov Pharmaceuticals, Ltd.	Phase 3	2014-06-26	The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with newly diagnosed hypertension requiring antihypertensive therapy. This study was conducted to support a future marketing application for KIT-302. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study, two separate capsules were utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched placebo tablet. The study hypothesis was that treatment with the amlodipine besylate containing capsule plus the celecoxib containing capsule would reduce blood pressure (BP) in subjects with hypertension with an efficacy that is not substantially inferior to the effect of amlodipine besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the celecoxib capsule). The United States (US) Food and Drug Administration (FDA) recently approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
NCT02979197 ↗	Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives	Completed	Kitov Pharma Ltd	Phase 3	2016-11-03	The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate on renal and vascular function in subjects with existing hypertension requiring antihypertensive therapy. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study (KIT-302-03-02), commercial celecoxib capsules (Celebrex®) and commercial amlodipine besylate tablets (Norvasc®) were separately over-encapsulated (OE) and matched placebos were used to allow for blinding. Kitov completed a phase 3 pivotal trial in subjects with newly diagnosed hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was statistically non-inferior to amlodipine monotherapy with regard to reduction of blood pressure. Further, trends towards superior blood pressure lowering effects and improved renal function were observed for the combination. This study (KIT-302-03-02) was conducted to quantify the beneficial renovascular effects noted in the prior study in subjects with existing hypertension requiring antihypertensive therapy. On May 31, 2018, the United States (US) Food and Drug Administration (FDA) approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
NCT02979197 ↗	Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives	Completed	Kitov Pharmaceuticals, Ltd.	Phase 3	2016-11-03	The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate on renal and vascular function in subjects with existing hypertension requiring antihypertensive therapy. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib. The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study (KIT-302-03-02), commercial celecoxib capsules (Celebrex®) and commercial amlodipine besylate tablets (Norvasc®) were separately over-encapsulated (OE) and matched placebos were used to allow for blinding. Kitov completed a phase 3 pivotal trial in subjects with newly diagnosed hypertension (KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was statistically non-inferior to amlodipine monotherapy with regard to reduction of blood pressure. Further, trends towards superior blood pressure lowering effects and improved renal function were observed for the combination. This study (KIT-302-03-02) was conducted to quantify the beneficial renovascular effects noted in the prior study in subjects with existing hypertension requiring antihypertensive therapy. On May 31, 2018, the United States (US) Food and Drug Administration (FDA) approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for AMLODIPINE BESYLATE; CELECOXIB

Condition Name

Condition Name for AMLODIPINE BESYLATE; CELECOXIB
Intervention	Trials
Hypertension	2
Metastatic Cancer	1

Condition MeSH

Condition MeSH for AMLODIPINE BESYLATE; CELECOXIB
Intervention	Trials
Hypertension	2
Neoplasm Metastasis	1

Clinical Trial Locations for AMLODIPINE BESYLATE; CELECOXIB

Trials by Country

Trials by Country for AMLODIPINE BESYLATE; CELECOXIB
Location	Trials
United Kingdom	8
China	1

Clinical Trial Progress for AMLODIPINE BESYLATE; CELECOXIB

Clinical Trial Phase

Clinical Trial Phase for AMLODIPINE BESYLATE; CELECOXIB
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for AMLODIPINE BESYLATE; CELECOXIB
Clinical Trial Phase	Trials
Completed	2
Unknown status	1

Clinical Trial Sponsors for AMLODIPINE BESYLATE; CELECOXIB

Sponsor Name

Sponsor Name for AMLODIPINE BESYLATE; CELECOXIB
Sponsor	Trials
Kitov Pharmaceuticals, Ltd.	2
Kitov Pharma Ltd	1
Alphacait, LLC	1

Sponsor Type

Sponsor Type for AMLODIPINE BESYLATE; CELECOXIB
Sponsor	Trials
Other	3
Industry	2

Last updated: May 12, 2026

Amlodipine Besylate and Celecoxib Clinical Trials Update, Market Analysis, and 2025-2030 Projections

Executive summary: Amlodipine besylate remains a mature, high-volume antihypertensive with incremental life-cycle activity focused on fixed-dose combinations, adherence-focused dosing strategies, and safety-focused labeling. Celecoxib stays a core NSAID franchise with trials and regulatory activity oriented around COX-2 selectivity positioning, cardiometabolic risk mitigation, expanded use populations, and new formulations (including topical/controlled-release positioning in parts of the pipeline). Combined, the two drugs face different risk profiles: amlodipine competes mainly on price and combination formats; celecoxib competes on safety labeling, line-extension differentiation, and payer formulary access. Market growth to 2030 is expected to be modest on absolute terms for both, with celecoxib showing more variation by geography and indication mix.

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What is the latest clinical trials update for amlodipine besylate?

Fast answer: Recent clinical activity for amlodipine is dominated by (1) fixed-dose combination studies (amlodipine plus ARBs and other antihypertensives), (2) comparative effectiveness trials vs other first-line agents, and (3) real-world evidence-linked pharmacovigilance and adherence endpoints. The major clinical objective remains BP control and tolerability, with an emphasis on peripheral edema mitigation via regimen optimization rather than new molecular entities.

Which study types are driving the amlodipine pipeline now?

1. Combination therapy trials

   • Amlodipine is commonly paired with:
     • ARBs (eg, valsartan, losartan-like pairings)
     • ACE inhibitors (eg, benazepril-like pairings)
     • Thiazides or thiazide-like diuretics
   • Trial endpoints: mean SBP/DBP change, BP responder rates at set timepoints, adherence, and discontinuation due to edema.

2. Tolerability and safety-focused studies

   • Peripheral edema is the key differentiator risk.
   • Studies often compare dose titration schedules, baseline risk stratification, or co-therapy intended to offset fluid retention effects.

3. Real-world evidence

   • Claims and EHR studies track persistence and refill gaps, often mapped to clinical outcomes and HRQoL measures.

What regulatory signals matter for amlodipine clinical development?

• Labeling updates across major jurisdictions typically concentrate on:
  • Hypertension and comorbidity context
  • Adverse reaction frequency/management language
  • Pediatric extrapolation where applicable for antihypertensives, depending on country-specific frameworks
• No new clinical “platform” is emerging that would structurally change amlodipine’s competitive dynamics versus entrenched generics.

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What is the latest clinical trials update for celecoxib?

Fast answer: Celecoxib clinical updates in the current cycle are centered on:

• Indication refinements within osteoarthritis and chronic musculoskeletal pain settings
• Cardiovascular and GI risk mitigation strategies using dose selection, duration framing, and patient-selection algorithms
• Controlled-release and formulation work (where pursued) to improve tolerability or onset profiles
• Safety and effectiveness comparisons against other NSAIDs and within multimodal pain regimens

Which endpoints are most common in recent celecoxib studies?

1. Efficacy endpoints

   • Pain intensity reduction (commonly WOMAC/AUS or similar scoring depending on disease)
   • Functional improvement and responder thresholds
   • NSAID rescue use patterns

2. Safety endpoints

   • GI adverse events
   • Cardiovascular composite endpoints (particularly in high-risk cohorts)
   • Hypertension, edema, and renal function signals

3. Risk management

   • Stratification for prior CV events
   • Concomitant gastroprotection usage tracking in real-world programs
   • Comparators often include non-selective NSAIDs or other COX-2 agents

How do trial designs affect the market outlook for celecoxib?

• Trials that strengthen evidence for safer use in defined populations can improve payer acceptance and reduce formulary friction.
• Trials framed around combination regimens and minimizing duration can support line-extension competitiveness even without major new patents in most markets.

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How big are the global markets for amlodipine besylate and celecoxib today?

Fast answer: Both drugs are established generics in most geographies, with market size driven by volume and payer access rather than premium pricing. Amlodipine is a top-tier antihypertensive by prescription volume worldwide. Celecoxib is smaller by volume than the widest generics but remains meaningful through chronic pain and osteoarthritis incidence and ongoing physician reliance.

Market structure

• Amlodipine
  • Dominated by generics and fixed-dose combinations
  • Competitive intensity based on:
    • Pricing
    • Availability in combination “bundles”
    • Regional tendering and state-level procurement dynamics
• Celecoxib
  • Mix of generics and branded residues depending on jurisdiction
  • Competitive intensity based on:
    • Formulary tier placement
    • Prescriber comfort with COX-2 safety messaging
    • Generic entry timing and local pricing

Pricing and net revenue drivers

• Net revenue depends on:
  • Generic discounting and channel inventory cycles
  • Tender pricing (where applicable)
  • Reimbursement rules for COX-2 and NSAIDs
  • Migration into combination products for amlodipine and into selected pain subsegments for celecoxib

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What are the 2025-2030 projections for amlodipine besylate market growth?

Fast answer: Expect low-to-mid single-digit growth rates in value terms globally through 2030, driven mainly by population aging, hypertension prevalence, and ongoing combination uptake, partially offset by generic price erosion.

Key growth and headwinds

Growth drivers

• Continued antihypertensive adoption and titration in primary care
• Fixed-dose combination expansion to improve persistence and BP outcomes
• Ongoing guideline support for calcium channel blockers as first-line options in many regions

Headwinds

• Persistent price pressure as generics saturate formularies
• Edema-related discontinuations that can shift patients to alternative regimens
• Competitive substitution within classes (other dihydropyridines and ARB-based regimens)

Projection ranges (scenario-based)

• Base case: modest value growth, low volume growth, and incremental combination share gains
• Downside: faster price erosion and slower combination migration
• Upside: stronger combination uptake and fewer discontinuations improving persistence

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What are the 2025-2030 projections for celecoxib market growth?

Fast answer: Expect growth that tracks pain incidence and treatment patterns, but with greater variability than amlodipine due to safety-driven prescribing shifts, reimbursement restrictions, and generic penetration speed.

Key growth and headwinds

Growth drivers

• Chronic osteoarthritis prevalence and long-term pain management demand
• Physician preference for COX-2 selective NSAID positioning when risk balancing supports use
• Potential uptake of newer formulations or improved patient-selection protocols

Headheads

• COX-2 class risk perceptions and label-driven prescribing constraints
• Switches to non-NSAID analgesics or topical/adjunct approaches in some payer environments
• Competitive pressure from multiple NSAID generics and local supply dynamics

Projection ranges (scenario-based)

• Base case: low-to-mid single-digit value growth with stable to slightly growing volume, depending on region
• Downside: tighter COX-2 restriction policies and faster competitor substitution
• Upside: favorable real-world evidence adoption that improves formulary positioning and persistence

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How does generic competition affect amlodipine vs celecoxib?

Fast answer: Amlodipine faces highly mature generic competition with combination format differentiation doing most of the work. Celecoxib faces competitive pressure too, but uptake depends more on COX-2 risk-benefit messaging, dosing strategy, and indication-level prescribing behavior.

Competitive dynamics

• Amlodipine
  • Multiple interchangeable generic entrants
  • Differentiation shifts to:
    • Fixed-dose combinations
    • Manufacturing reliability
    • Contracting and tender access
• Celecoxib
  • Differentiation shifts to:
    • Formulary decisions around NSAID risk management
    • Adherence to duration/dose minimization
    • Patient selection and comorbidity guidance

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Are there biosimilar risks for amlodipine or celecoxib?

Fast answer: No biosimilar risk exists because both are small molecules, not biologics.

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Which formulations are likely to impact amlodipine and celecoxib share most?

Fast answer: For amlodipine, fixed-dose combinations and dose titration regimens are the main formulation-adjacent levers. For celecoxib, controlled-release and formulation tweaks (where adopted) influence tolerability and adherence more than mechanism-level differentiation.

Amlodipine

• Oral immediate-release remains the core format.
• Fixed-dose combination products expand addressable patient segments by reducing pill burden.

Celecoxib

• Oral systemic formulations dominate.
• Formulation evolution tends to target:
  • GI tolerance
  • Onset or duration of analgesic effect
  • Treatment convenience in chronic conditions

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What patent or exclusivity constraints affect market projection for these drugs?

Fast answer: Both products are largely outside meaningful exclusivity constraints in most major markets; market outcomes primarily depend on generic competition, formulary access, and life-cycle regulatory updates rather than ongoing exclusivity from primary molecule patents.

Practical IP implications

• Amlodipine: patent estates are largely exhausted; competition centers on generic entry and combination products.
• Celecoxib: legacy exclusivity has largely expired in major markets; competitive outcomes track generic availability and regulatory labeling/brand positioning where remnants exist.

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What generic entry risks exist for amlodipine and celecoxib in the US and EU?

Fast answer: Entry risk is mostly “already realized” in many established markets due to extensive generic saturation. Near-term risk in specific jurisdictions comes from:

• Remaining localized brand residue and supply contracts
• Combination-product patent status at a country level
• Tender cycles and procurement transitions

Where entry can still change near-term share

• Combination products: market share can shift materially if barriers to combination substitution clear.
• Formulation variants: controlled-release or specialty pack changes can delay substitution in some channels.

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What litigation or settlement dynamics affect amlodipine or celecoxib?

Fast answer: Litigation is not a primary driver of current market structure for these mature small molecules; it is more relevant when focusing on specific combination products, brand remnants, or localized distributor contracts. For broad molecules, the market is primarily shaped by generic availability and pricing.

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What is the Orange Book status of amlodipine and celecoxib?

Fast answer: Both are mature small molecules with extensive generic coverage; Orange Book listings are dominated by generic entries across strengths and dosage forms, with any remaining branded or listed exclusivities varying by product and NDA labeling history. Broad-molecule guidance: no single active exclusivity is likely to anchor long-term projection for these drugs without narrowing to a specific NDA, strength, or formulation.

(No additional Orange Book element can be stated accurately here without naming specific NDA numbers and listing-level expiration dates.)

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Amlodipine vs celecoxib: how do risks and growth drivers compare?

Dimension	Amlodipine besylate	Celecoxib
Primary use	Hypertension, cardiovascular risk management	Osteoarthritis, chronic musculoskeletal pain
Competitive basis	Price, combination penetration, persistence	Formulary access, CV/GI risk positioning, prescribing behavior
Market growth pattern	Stable, volume-driven; low value growth due to erosion	More variable; driven by indication mix and risk policy
Key clinical differentiator	Edema management via regimen/titration and combinations	Safer COX-2 narrative within patient selection
Expected 2025-2030 trajectory	Low-to-mid single-digit value growth globally	Low-to-mid single-digit with higher range spread by region

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Key Takeaways

• Amlodipine besylate remains a mature, high-volume antihypertensive where market outcomes are driven by generic price competition and fixed-dose combination adoption, with growth likely modest through 2030.
• Celecoxib shows more variability due to safety-driven prescribing, reimbursement constraints, and indication-specific demand, with market growth likely modest but uneven across geographies.
• For both drugs, the near-to-mid term is dominated by channel economics and formulary access rather than molecule-level exclusivity.
• The practical lever for share is product format: amlodipine combinations for persistence and convenience; celecoxib selection and tolerability strategies for payer and prescriber acceptance.

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FAQs

1. Which fixed-dose combinations of amlodipine most affect US and EU market share?
2. Do COX-2 risk communications change celecoxib formulary placement more than NSAID price?
3. How do tender procurement cycles in major markets influence amlodipine generic pricing?
4. What real-world adherence metrics are most predictive of celecoxib persistence in chronic osteoarthritis?
5. What is the fastest-growing indication for celecoxib by country and payer segment?

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. EMA. (n.d.). European public assessment reports (EPAR) and product information. European Medicines Agency.
3. ClinicalTrials.gov. (n.d.). Amlodipine besylate studies; celecoxib studies. U.S. National Library of Medicine.